Medical cleaning apparatus

ABSTRACT

An improved cleaning and sterilizing apparatus adapted for cleaning and sterilizing medical instruments in which a wash cycle and rinse cycle are repeated if proper cleaning of the instrument has not been obtained. Using a turbidity monitor or comparable instrument, an indicia representative of the particles in the rinse water is obtained. If the indicia does not meet some pre-defined standard, such as those set by the Food and Drug Administration, then the wash/rinse cycles are repeated. This is done either until the standards are met or for a certain number of times. If the standards are met, then the medical instrument is sterilized for later use. In the preferred embodiment, proper sterilization is monitored by the turbidity monitor.

This is a continuation-in-part of U.S. patent application Ser. No.08/698,392, entitled "Medical Cleaning and Sterilizing Apparatus" filedAug. 14, 1996, now U.S. Pat. No. 5,711,921, issued Jan. 27, 1998 whichwas a continuation-in-part of U.S. patent application Ser. No.08/582,849, entitled "Cleaning and Sterilizing Mechanism" filed Jan. 2,1996, now U.S. Pat. No. 5,753,195 issued May 19, 1998.

BACKGROUND OF THE INVENTION

This invention relates generally to mechanisms used to clean tubularitems and more particularly to mechanisms used to sterilize as well.

The apparatus of this invention is particularly well suited forendoscope cleaning and sterilization. Other areas of applicationinclude: dental tools, surgical instruments, implants, etc.

Endoscopes are flexible tubes having a multiplicity of endings. Merelysoaking endoscopes in a sterilant or detergent is unacceptable sincenumerous pockets exist within the tubing where the sterilant ordetergent cannot reach effectively. This leaves areas of contaminationwithin the endoscope. With the prevalence of highly contagious diseasessuch as hepatitis B and Acquired Immune Deficiency Syndrome,sterilization or disposal of all medical tools becomes mandatory.

Once used, endoscopes are usually discarded due to the complexity ingetting the endoscope sterilized before any subsequent uses. Endoscopesthemselves are extremely expensive so their disposal after one use isseen as wasteful since the structural integrity of the endoscope has notbeen jeopardized by its use, only its sterile nature.

It is clear from the foregoing that there is a significant need for adevice which will assist in cleaning a device and improve thesterilizing effects.

SUMMARY OF THE INVENTION

The present invention creates a cleaning and sterilizing apparatusadapted for cleaning and sterilizing medical instruments. While thefollowing discussion relates to an apparatus which both cleans medicalinstruments of bio-burden and also sterilizes the medical instrument,the invention is intended to also encompass an apparatus which solely isintended to clean the medical instrument of its bio-burden.

The cleaning operation of this invention preferably uses cycles ofwashing (usually with a detergent) and then a rinse with fresh water.The water from the rinse is monitored to see if the particulate matterwithin the rinse meets a preset standard.

Should the particulate matter not meet the standard, the wash cycle andrinse cycle are repeated. In one embodiment of the invention, thiswashing/rinsing is conducted several times before the apparatus "givesup" and informs the user that the medical instrument is beyond cleaningand should be disposed.

This case can occur when the instrument itself begins to break down,thereby producing particulate matter that no level of washing willtotally remove.

To accomplish this task, a turbidity monitor or comparable instrument isused to create an indicia representative of the particles in the rinsewater. A variety of such instruments are well known in the art andinclude those techniques described in: U.S. Pat. No. 5,560,060, entitled"System and Method for Adjusting the Operating Cycle of a CleaningAppliance" and issued to Dausch et al. on Oct. 1, 1996; or U.S. Pat. No.5,555,583, entitled "Dynamic Temperature Compensation Method for aTurbidity Sensor used in an Appliance for Washing Articles" issued toBerkcan on Sep. 17, 1996; or U.S. Pat. No. 5,341,661, entitled "SensorHolder having a Container with a Projection for Collecting Fluid Samplesin a Machine for Cleansing Article" issued to Dausch on Aug. 30, 1994;all of which are incorporated hereinto by reference.

The standard which is used for passing from the wash/rinse cycle ischosen to meet the standards of the time or the situation. The preferredstandard is set forth by the Food and Drug Administration which sets forstandards, including flow-rate and size of particles found inParticulate Matter in Injections, commonly known as USP 788Specification.

If the standards are met, then the medical instrument is sterilized forlater use. In the preferred embodiment, the rinse from the sterilant isalso gauged by the sensor to see that all of the biological growth hasbeen eliminated. This is accomplished by scanning the rinse stream forlife particles having a size of greater than 2 microns.

Within this discussion, endoscopes will be used as an example of an itemto be cleaned, but, the invention is not intended to be limited to thisone item. Rather, the invention contemplates its use with any tubularitem as well as a variety of other items such as circuit boards, medicalinstruments, dental instruments, and other items in which cleaningand/or sterilization is required.

In this invention, a container is partitioned into two chambers with theendoscope positioned to extend through the partition such that oneopening of the endoscope lies in one chamber and another opening of theendoscope lies in the other chamber.

The partition between the chambers need not be an absolute partition andin the preferred embodiment, the partition fits loosely around theendoscope so that as the medium, (i.e. a liquid detergent, sterilewater, a liquid sterilant, or a sterilant gas) surges from one chamberto the other, the medium washes over the exterior of the endoscope andis affected by the medium while the medium simultaneously sweeps throughthe interior of the endoscope.

In the creation of the surge, a flexible membrane is positioned toaffect each chamber. By deforming the flexible membrane, inward andoutward, a pressure or suction is created which results in a flowbetween the chambers to equalize the pressure between the chambers.

Deformation of the flexible membrane is accomplished in the preferredembodiment using air pressure which is exerted on an exterior portion ofthe membrane to deform it into the chamber; to accomplish the reverseflow, an external suction pulls the membrane from the chamber.

In the preferred embodiment, two flexible membranes or diaphragms areused. Each membrane addresses one of the chambers and the membranes areoperated in a "reverse-gang" relationship. That is, as external pressureis being applied to one membrane, external suction is being applied tothe other membrane. This reverse-gang relationship produces heightenedmedium flow within the container and increases the cleansing and/orsterilizing action.

This flow of medium must pass through the endoscope. Mechanical pressurefrom the medium flow assists in cleaning the endoscope. If a sterilantis used as the liquid medium, then the interior portion of the hollowitem is also sterilized.

The preferred liquid sterilant is peracetic acid and the preferred gassterilant is ethylene-oxide (ETO). Those of ordinary skill in the artreadily recognize various other sterilants which can be used in thiscontext.

By reversing the flow between the chambers, a "scrubbing" action iscreated which dislodges and removes debris and other contaminants fromthe interior and exterior of the endoscope.

In some embodiments of the invention, a soak or solvent is used to helpbreak down or loosen the debris. This step is particularly useful forthe removal of protein or fat particles.

In the preferred embodiment, the endoscope is first cleaned using adetergent. Afterwards, a sterilant is applied using a gentle flowbetween the chambers. In some embodiments of the invention, the pumpingaction is stopped to permit the sterilant to rest against theendoscope's interior and exterior so that a maximum sterilizing effectis obtained.

As a final step in the preferred embodiment, the sterilant is removedand sterile water is washed over and through the endoscope inpreparation for subsequent use with a patient. Some embodiments of theinvention also add a lubricant rinse and soak to extend the life of theendoscope.

The invention, together with various embodiments thereof will be morefully explained by the accompanying drawings and the followingdescriptions.

DRAWINGS IN BRIEF

FIG. 1 is a layout view of the preferred embodiment of the invention.

FIG. 2 is a close-up view of one of the membranes illustrated first inFIG. 1.

FIG. 3 is a layout of the preferred controller/valve system.

FIG. 4 is a schematic of the pump illustrated in the embodiment of FIG.1.

FIGS. 5A and 5B are side views illustrating two membranes working in agang relationship to create the desired surge.

FIG. 6 is a top view illustrating the flow from one chamber to anotherthrough the endoscope.

FIG. 7 is an alternative embodiment of the invention in which a singlemembrane is used.

FIG. 8 is an alternative embodiment of the invention in which fourmembranes are utilized to create more surge effect.

FIG. 9 is a perspective view of an embodiment in which the container isremovable from the membrane system.

FIG. 10 is a block diagram of the layout of an embodiment of theinvention.

FIG. 11A is a block diagram of the drying mechanism of the preferredembodiment which uses ambient air.

FIG. 11B is a block diagram of the purging mechanism used to purge gasfrom the cleaner/sterilizer.

FIGS. 12A and 12B are top and side views of an embodiment of theinvention in which flat items are cleaned.

FIG. 13 is a perspective view of an embodiment of the invention.

FIG. 14 is a frontal view of an embodiment of the invention.

FIG. 15 is a frontal view of the fly-wheel used in the embodiment ofFIG. 14 showing the suction/compression relationship.

FIG. 16 illustrates the operation of the preferred embodiment of theturbidity sensor.

FIG. 17 is a flow-chart of the preferred operation of the controllermechanism.

DRAWINGS IN DETAIL

FIG. 1 is a layout view of the preferred embodiment of the invention.

Cleaner 10 has five major components: lid 11; base unit 12 with legs 13Aand 13B; membrane pump 21; controller and valves 23 and reservoirs 25(or alternatively gas tanks 26).

Lid 11 is hinged to base unit 12 and is secured in a closed position bylatches 14. Lid 11 is sealed around its periphery with base unit 12 toform an air tight container.

Seal 17 is designed to mate with seal 18 to divide container 8 intochambers 9A and 9B. The endoscope, not shown, is positioned to passthrough recesses 19 in seal 18 such that one end of the endoscope liesin chamber 9A while the other end of the endoscope lies in chamber 9B.When lid 11 is closed and sealed, seal 17 completes the seal around theendoscope.

In this embodiment, each leg, 13A and 13B, are hollow and communicatewith container 8 via an opening such as opening 15A.

Each leg 13A and 13B is also provided with a port such as port 22Bthrough which a medium (a liquid or gas) is communicated. By supplying amedium to the port, and since the hollow leg communicates with container8, the container is filled with whatever medium is desired.

Each leg further includes a flexible membrane 20 which communicates withthe hollow portion of the leg.

Membrane pump 21 is used to selectively deform flexible membrane 20 andin so doing create a pumping action through container 8.

Membrane pump 21 is controlled by controller and valves 23 which acts asthe central "brains" in controlling the operation of the apparatus. Whenthe endoscope has been properly placed within container 8 and lid 11 hasbeen closed, controller 23 draws a selected medium, a liquid in thisillustration, from reservoirs 25 and communicates this liquid to port22B. In an alternative embodiment, a gas from container 26 is used asthe medium.

Once container 8 has been properly filled, controller 23 initiates apumping action via pump 21 and the flexible membranes 20. The pumpingaction from pump 21 oscillates between a pressure and a suction so thateach flexible membrane moves inward and outward to cause the medium toflow between chamber 9A and 9B.

The medium flow between the chambers 9A and 9B naturally flows throughthe endoscope and as such forces the medium throughout the endoscope. Ina cleaning operation, the mechanical force exerted by the medium removesdebris from the inside of the endoscope.

In the preferred order of cleaning and sterilizing, the steps taken bythe operator are:

Step 1: Placement of endoscope into container 8, closure of lid 11, andsecurement of lid 11 via clamps 14; and,

Step 2: Initiate process by activating controller 23.

The system then proceeds through its sequence of steps:

Step 1: Container 8 is filled with an enzyme/solvent to loosen proteinand fat from the walls of the endoscope;

Step 2: Fill container 8 with a detergent from one of the reservoirs 25;

Step 3: Agitate by oscillating a pumping action between chambers 9A and9B using pump 21 and flexible membranes 20;

Step 4: Drain container 8 and discharge into drain 24;

Step 5: Fill container 8 with a sterilizing agent such as ozone, orothers known to those of ordinary skill in the art, from one of thereservoirs 25;

Step 6: Gently oscillate the sterilizing agent through the endoscopeusing pump 21 and membranes 20 (a lubricant may be added at this point);

Step 7: Permit the sterilizing agent to stand within the endoscope;

Step 8: Gently oscillate the sterilizing agent through the endoscopeusing pump 21 and membranes 20;

Step 9: Drain container 8 and discharge into drain line 24 while heatingcontainer via heating element 16 (an alternative technique is to dryusing filtered air).

Step 10: The flow through drain line 24 passes turbidity monitor 160which generates a turbidity indicia which is communicated controller 23.If the turbidity indicia does not meet a pre-set standard or criteria,then the cycle is repeated in an attempt to properly clean the medicalinstrument.

As a quality control mechanism, sampler 7 is solenoid driven and draws asample of the liquid or gas medium within container 8. This sample isthen subjected to testing using chemical and biological indicators whichreveal if the sterilizing process has been successful.

Heater element 16 is used to vaporize any liquids so that they too canbe drawn from container 8 to leave a clean, sterile, and dry, endoscopewithin container 8.

In an alternative embodiment, filtered ambient heated air is pumpedthrough container 8 to dry the items therein.

FIG. 2 is a close-up view of one of the membranes illustrated first inFIG. 1.

As before, base unit 12 includes a container 8 which communicates withleg 13A via opening 15A. Port 22A permits the introduction andwithdrawal of medium from container 8.

Hollow portion 31 is within leg 13A and is in communication withflexible membrane 30A. Positioned over flexible membrane 30A is a rigidcover 5. A pipe/tube communicates an interior formed by the rigid cover5 with pump 21. Pump 21, because of this arrangement, is able to eitherpressurize or de-pressurize the interior portion of rigid cover 5. In sodoing, flexible membrane 30A deforms inward, 30C, under pressure; anddraws outward, 30B, in a suction mode.

This movement of flexible membrane 30A between positions of 30B and 30C,provides a pumping action which pushes and pulls medium throughcontainer 8.

FIG. 3 is a layout of the preferred controller/valve system.

Controller with valves 23 communicates the medium using fittings 38A,38B, 38C, 38D, and 38E. Each fitting is opened or closed using solenoids37A, 37B, 37C, 37D, and 38E respectively. All of these communicate withpump 36 to form the valving system.

Connected to pump 36 and each solenoid 37A, 37B, 37C, 37D, and 37E, iscontroller chip 33 which is used to coordinate all operation. Power tocontroller chip 33 is provided by standard electrical outlets 35 whichpasses through an appropriate transformer to provide proper voltage andcurrent for the demands of the electronic system. Those of ordinaryskill in the art readily recognize which transformers are to be used inthis context.

Timing chip 34 provides a timing base from which controller 33 operates.

Controller 33 further communicates with membrane pump 21 via connector32A and 32B.

Initiation of the operation is communicated by operator activation ofbutton 39. Thereafter, controller 33 communicates a status report usinglights 4 which are selectively activated during operation of theapparatus.

FIG. 4 is a schematic of the pump illustrated in the embodiment of FIG.1.

Membrane pump 21 is composed of a piston block 41 which includes twopistons. These pistons are driven by electric motor 42 and drive shaft43. One piston draws in air 40A while the other piston exhausts air 43B.The pressure and suction from piston block 41 is communicated to valveblock 45.

Valve block 45 is a reciprocating valve which is operated by solenoid44. As a reciprocating valve, valve block 45 selectively directs thepressure to either port 46A or port 46B; simultaneously, the suctionprovided from piston block 41 is directed to the other port. As example,when pressure is supplied to port 46A, suction is provided to port 46B,and vice versa.

In this manner, for a two flexible membrane system, while one membraneis being pressured into the hollow of one leg, the other membrane isbeing drawn from the hollow of its leg. This dual action creates a moredramatic pumping action and creates a greatly enhanced cleaningpotential.

FIGS. 5A and 5B are side views illustrating two membranes working in agang relationship to create the desired surge.

As shown in simplified form in FIG. 5A, for the cleaner/sterilizer 50,by drawing flexible membrane 51A from the hollow in the leg whileforcing flexible membrane 52A into the hollow, the medium flows asindicated by arrow 53A through partition 18.

In opposite fashion, by pressing flexible membrane 51B into the hollowand drawing flexible membrane 52B from the hollow, the flow of medium isreversed as shown by arrow 53B.

Through the selective oscillation between the two states shown in FIGS.5A and 5B, the flow of medium through the endoscope, not shown, iscontinuously reversed creating a scrubbing affect in the endoscope.

FIG. 6 is a top view illustrating the flow from one chamber to anotherthrough the endoscope.

Endoscope 60 is position through seal 18 as described above so that oneend of endoscope lies in chamber 9A while the other end lies in chamber9B. By the pumping action described above, medium is either drawn orexpelled through openings 15A and 15B into chambers 9A and 9Brespectively. This pumping action forces the medium to flow into one endof endoscope 60, as illustrated by arrow 62, and to exit out the otherend, as illustrated by arrow 61.

The flow of the medium through endoscope 60 flushes debris from theinterior of the endoscope and significantly enhances the operation overthe prior art.

FIG. 7 is an alternative embodiment of the invention in which a singlemembrane is used.

In this embodiment of cleaner/sterilizer 70, a single membrane 71 isused to create the pumping action with container 8. As before, endoscope60 is positioned to extend through the partition formed by seal 18 andseal 17. As membrane 71 is pressed into container 8, a surge of themedium flows through endoscope to assist in cleansing of the interior ofthe endoscope.

Ports 22A and 22B provide for drainage and filling openings so that theselected medium can be installed and drained from container 8.

Note that in this embodiment, membrane 71 communicates directly withcontainer 8 and as such, the legs of cleaner 70 can be shortenedpermitting this embodiment to be used in many locations where space is aconcern.

FIG. 8 is an alternative embodiment of the invention in which fourmembranes are utilized to create more surge effect.

Again, endoscope 60 is positioned within container 8 through seal 17 andseal 18. In this embodiment, to provide for an even greater surge of themedium through endoscope 60, four membranes 80A, 80B, 80C, and 80D, areused in a gang relationship with the membranes combined in pairs to worksimultaneously to provide either pressure or suction pumping. Asexample, when membrane 80A is pressurized, so is membrane 80B.

Those of ordinary skill in the art readily recognize that any number ofmembranes may be used in this context. By varying the number ofmembranes used, the designer is able to obtain the desired pumpingaction, and as an extension, the surge.

FIG. 9 is a perspective view of an embodiment in which the container isremovable from the membrane system.

Cleaner 92 provides a seat 93 into which container 90 is nested. Duringthe nesting process, valves 94A and 94B mate with their reciprocalparts, not visible in this view, of container 90. Valves 94A and 94B,and their reciprocal counterparts, seal upon disengagement so that thecontents of container 90 maintain their clean and/or sterile integritywhen container 90 has been removed. This permits the endoscope to becleaned and/or sterilized and then stored without fear of contamination.When the surgeon is ready to utilize the endoscope, removal of clamps 14and the lifting of lid 11 makes the sterile endoscope available for use.

As discussed before, flexible membranes 95A and 95B are located on basemember 92 and provide the pumping action discussed. This pumping actionis communicated to container 90 via valves 94A and 94B. The operation ofthis cleaner is similar to that already discussed.

Removal of container 90 is facilitated using handles 91A and 91B. Onceremoved, container 90 may be stored for later use or may be opened forimmediate use of the endoscope.

FIG. 10 is a block diagram of the layout of an embodiment of theinvention.

Water source 100 is directed, by way of valves 101A and 101B, to eithercontinue on its course or to pass through flash heater 102. Flash heater102 is chosen to heat the water to a desired temperature which is ofoptimal assist for a medium contained in one of the reservoirs.

Reservoirs 103A, 103B, 103C, 103D, and 103E, in this embodiment, containan enzyme soak (used to loosen fats and proteins from the skin of theendoscope), a detergent (used to wash debris from the endoscope), anacid sanitizer (used to adjust the PH within the container), a sterilant(used to sterilize the endoscope), and a lubricant (used to lubricatethe endoscope for use in the surgical field), respectively. Thecontroller, not shown in this illustration, controls the valves 101A and101B as well as the injection of medium from the various reservoirs103A, 103B, 103C, 103D, and 103E.

As a safety feature, each reservoir is identified by an electronic chipwhich communicates with the controller. This chip absolutely identifiesthe reservoir's contents so that an improperly connected reservoircannot discharge its contents at the wrong time.

The stream is then directed to the cleaner/sterilizer 10 where theproper operation is conducted as outlined above. At the option of theoperator, sampler 7 draws a medium sample from the container. Thissample is used to confirm that the endoscope has been properly cleanedand sterilized.

At selected points with the operation, the medium is drained fromcleaner/sterilizer 10 and the material passes through indicator 104where the material is tested by a chemical and biological indicator toassure that unacceptable contaminants do not pass to drain 24.

In one embodiment, a second flash heater is used after indicator 104.This flash heater is designed to heat the discharge to such atemperature that all biological contaminates are destroyed prior todischarge into the drain. Yet another embodiment positions a flash heatbefore indicator 104 to accomplish the same task.

FIG. 11A is a block diagram of the drying mechanism of the preferredembodiment which uses ambient air.

In some situations, the use of ambient air 110 is made to assist in thedrying of the endoscope within the cleaner/sterilizer. For ambient airto be properly used, pump 111 pushes the air through filters 112 priorthe air being passed along to cleaner 10.

Filters 112 are chosen to remove particles (including biological agents)from the air so that the endoscope within the cleaner 10 is notre-contaminated. Those of ordinary skill in the art readily recognizevarious filters which can be used in this context.

FIG. 11B is a block diagram of the purging mechanism used to purge gasfrom the cleaner/sterilizer.

When a sterilizing gas is used within the container, it is advisable topurge the container of the gas. This is accomplished safely through theuse of filter 114 through which blower 113 draws the gas from cleaner10. If peracetic acid is used as the sterilizing gas, filters 114 arepreferably moistened sponges. In other embodiments, activated charcoalis used to cleanse the gas before it is discharged as exhaust 115.

Those of ordinary skill in the art readily recognize various otherfilters which can be used in this context.

FIGS. 12A and 12B are top and side views of an embodiment of theinvention in which flat items are cleaned.

Operator 126 uses handle 127 and caddie 124 to place item 125 (a printedcircuit board in this illustration) into cleaner 10. Cleaner 10 operatesas described above with drains 15A and 15B communicating with themembranes (not shown in this illustration).

In this embodiment, partition 18 is slightly wider and contains notchtype passages 120A and 12B through which the surge of medium flows, asillustrated by arrows 121. Vanes 122 redirect the flow as indicated byarrows 123 to pass the medium over item 125.

Through selective design of vanes 122, caddie 124 is designed to addressthe cleaning needs of a variety of different items so that optimalcleaning is obtained.

FIG. 13 is a perspective view of an embodiment of the invention.

As before, cleaning and sterilizing unit 130 has chamber 9A and chamber9B which are divided by partitions 17 and 18. Channels 19 are adapted toaccept the surgical instrument to be cleaned/sterilized.

In this embodiment, channel 136 is also formed to permit chamber 9A todrain into basin 131. Basin 131 forms a low point within the containerand is used to collect the liquid cleaner or sterilizer for discharge.

Piston pump 133 communicates with basin 131 and is driven by flywheel134 which is selectively driven by an electric motor (not shown). Asflywheel 134 rotates, piston pump 133 cycles between applying pressureand withdrawing pressure. This change in the liquid pressure causes theliquid to surge between chambers 9B and 9A. The surging action assistswith the cleaning action and assures that any steriliant is forcedthroughout the medical instrument.

The added liquid pressure created by piston pump 133 is absorbed byrubber wall 132 which flexes during added pressure permitting the liquidto be forced into chamber 9A. When piston pump 133 withdraws pressure,then rubber wall 132 returns to its at-rest position to assist inforcing the liquid back into chamber 9B.

In this manner, the cleaning or sterilizing liquid is washed/surged backand forth between the two chambers.

In this embodiment, the liquids are easily discharged through selectiveuse of solenoids 135A and 135B. During withdrawal of the piston withinpiston pump 133, solenoid 135A is opened permitting liquid to be drawninto piston pump 133. When piston pump 133 begins to apply pressure,solenoid 135A closes and solenoid 135B opens permitting the liquid to bedischarged to the drain 24. Hence, when the cleaning or sterilizingprocedure is complete, piston pump 133 easily discharges the liquid intothe drain.

FIG. 14 is a frontal view of an embodiment of the invention.

In this embodiment of the invention, cleaner/sterilizer 140 includes twochambers which communicate with the interior of leg portions 146A and146B. Piston pumps 141A and 141B communicate with the interior of theirrespective leg portions 146A and 146B. As piston pumps 141A and 141Bcycle, the liquid pressure within the chambers are either increased ordecreased.

Electric motor 143 is selectively driven to rotate flywheel 142. Pistonpumps 141A and 141B are connected to flywheel 142 in such a manner thatpiston pump 141A is always in an opposing cycle relative to piston pump141B. As example, as piston pump 141A is pressing the liquid, pistonpump 141B is drawing in liquid.

This alternative action between piston pump 141A and 141B creates asurging action between the chambers to obtain the action describedrelative to the other embodiments.

The cleansing and sterilizing liquids 144 are selectively communicatedto the chambers via valves 145. Exhaustion of the liquids and theaccumulated waste is via drain 24.

FIG. 15 is a frontal view of the fly-wheel used in the embodiment ofFIG. 14 showing the suction/compression relationship.

Flywheel 142 rotates as indicated by arrow 152. During such rotation,the connecting pin for the piston pumps, rotates between position 150Aand 150B. This rotation is broken into two basic components being zone153A and zone 153B.

When the connecting pin is in zone 153A, then the suction/compressiondirection is indicated by arrow 151A. When the connecting pin is in zone153B, then the suction/compression direction is indicated by arrow 151B.

In this manner, the suction/compression rotates in direction so that theliquid is forced to surge between the two chambers.

FIG. 16 illustrates the operation of the preferred embodiment of theturbidity sensor.

Fluid flows through drain line 24 and through a transparent section 166(preferably glass). As the fluid flows through this section, light fromlight source 165 (preferably a laser) is directed through transparentsection 166 and is monitored by receiver 164. Receiver 164 is acharge-coupled-device or other suitable mechanism which is responsive tolight.

Any absences of light are recorded as a particulate and communicatedfrom receiver 164 to counter 162. Counter 162 translates the pulses intoa count and communicates this to controller 163. Controller 163 createsa turbidity indicia which is communicated 161 to controller 23.

FIG. 17 is a flow-chart of the preferred operation of the controllermechanism.

Once start 170A, has occurred, a wash & drain operation is conducted171A followed by a rinse & drain operation 171B. During the drainportion of the rinse & drain, a turbidity indicia 172A is generated andreceived by the controller.

This turbidity indicia is compared to the standard, and if the criteriais not met, then a check 173B is made to see if the wash and rinse stepshave been performed enough times. A count of the wash/rinse is comparedto the maximum (preferably four), if the maximum has been met, then theoperator is advised to dispose of the surgical instrument 174B, and theoperation stops 170B.

If the maximum number of wash/rinse has not been met, 173B, then thecount number is raised by one 171D, and the wash & drain 171A isperformed again.

If the turbidity indicia meets or exceeds the standard, 173A, themedical instrument is then sterilized 171C. Again a turbidity indicia172B is received indicating the effectiveness of the sterilizingprocedure.

Should the turbidity indicia indicate that proper sterilization has notoccurred 173C, then the surgical item is again sterilized 171C.

Upon passing of sterilization 173C, the operator is advised that theitem is properly sterilized 174A, and the program stops 170B.

It is clear from the foregoing that the present invention creates ahighly improved cleaner for hollow items and also provides for theability to sterilize hollow items in a way heretofore unattainable.

What is claimed is:
 1. A medical cleaning apparatus comprising:a) atreatment mechanism accepting a surgical apparatus, said treatmentmechanism having means for:1) cleaning said surgical apparatus of debristhrough application of a wash cycle and a rinse cycle, 2) measuringturbidity of said rinse cycle and generating a turbidity indiciarepresentative thereof, and, b) control means for repeatedly causingsaid treatment mechanism to operate said means for cleaning until saidturbidity indicia passes a pre-selected criteria.
 2. The medicalcleaning apparatus according to claim 1,a) wherein said treatmentmechanism includes means for sterilizing said surgical apparatus; and,b) wherein said control means includes means for causing said treatmentmechanism to operate said means for sterilizing once said turbidityindicia passes said pre-selected criteria.
 3. The medical cleaningapparatus according to claim 2, wherein said control means includesmeans for causing said treatment mechanism to operate said means forsterilizing a second time if said turbidity indicia created while saidmeans for sterilizing operates does not meet a pre-set standard.
 4. Themedical cleaning apparatus according to claim 2, wherein said means forcleaning includes means for applying detergent during said wash cycle.5. The medical cleaning apparatus according to claim 2, wherein saidmeans for measuring turbidity include:a) a transparent tube in liquidcommunication with said treatment mechanism; b) a light transmitterdirecting light through said transparent tube; and, c) a light receiverpositioned to receive light passing through said transparent tube fromsaid light transmitter, said light receiver generating said turbidityindicia based upon interruptions in said light over a selected period oftime.
 6. The medical cleaning apparatus according to claim 5, furtherincluding means for directing a flow of liquid from said treatmentmechanism through said transparent tube.
 7. The medical cleaningapparatus according to claim 2,a) wherein said surgical apparatusincludes a hollow tube; and, b) wherein said treatment mechanismincludes means for selectively forcing liquids through said hollow tube.8. The medical cleaning apparatus according to claim 7, wherein saidmeans for selectively forcing liquids includes;a) a container having afirst chamber and a second chamber, said container accepting a medicalinstrument such that a first portion of said medical instrument lies insaid first chamber and a second portion of said medical instrument liesin said second chamber; b) a liquid medium contained within saidcontainer; and, c) pumping means for alternatively,1) increasingpressure within said first chamber while decreasing pressure within saidsecond chamber, and then, 2) increasing pressure within said secondchamber while decreasing pressure within said first chamber.
 9. Amedical apparatus cleaning mechanism comprising:a) a container having afirst chamber and a second chamber, said container accepting a medicalinstrument such that a first portion of said medical instrument lies insaid first chamber and a second portion of said medical instrument liesin said second chamber; b) means for injecting a liquid medium into saidcontainer; and, c) pumping means for increasing pressure within saidfirst chamber of said container, said pumping means including areciprocating piston having a first cylinder and a second cylinderadapted such that said first cylinder and said second cylinder havesubstantially equal displacement and wherein said first cylindercommunicates with said first chamber of said container and said secondcylinder communicates with said second chamber of said container forrepetitively,1) simultaneously, increasing fluid pressure within thefirst chamber of said container while decreasing fluid pressure withinthe second chamber of said container, and, 2) simultaneously, increasingfluid pressure within the second chamber of said container whiledecreasing fluid pressure within the first chamber of said container; d)means for flushing said liquid medium from said container; e) aturbidity monitor measuring turbidity of said liquid medium andgenerating a turbidity indicia representative thereof; and, f) means forrepeatedly causing said means for injecting, said pumping means, andsaid means for flushing to operate until said turbidity indicia meetspre-selected criteria.
 10. The mechanism according to claim 9,a) whereinsaid means for injecting a liquid medium includes means for injecting asterilizing liquid into said container; and, b) further includingcontrol means for causing said means for injecting to inject asterilizing liquid into said container once said turbidity indiciapasses said pre-selected criteria.
 11. The mechanism according to claim10, wherein said turbidity monitor includes:a) a transparent tube inliquid communication with said container; b) a light transmitterdirecting light through said transparent tube; and, c) a light receiverpositioned to receive light passing through said transparent tube fromsaid light transmitter, said light receiver generating said turbidityindicia based upon interruptions in said light over a selected period oftime.
 12. The mechanism according to claim 10, further including meansfor directing a flow of liquid from said treatment mechanism throughsaid transparent tube.
 13. A cleaning and sterilizing mechanismcomprising:a) a container having a first chamber and a second chamber,said first chamber in liquid communication with said second chamber; b)an item enclosed within said container such that a first portion of saiditem lies in said first chamber and a second portion of said item liesin said second chamber; c) means for injecting a selected liquid intosaid container; and, d) surging means having a reciprocating pistonhaving a first cylinder and a second cylinder adapted such that saidfirst cylinder and said second cylinder have substantially equaldisplacement and wherein said first cylinder communicates with saidfirst chamber of said container and said second cylinder communicateswith said second chamber of said container, said surging means forrepetitively causing said selected liquid to surge between said firstchamber and said second chamber; e) means for flushing said selectedliquid from said container; f) a turbidity monitor measuring turbidityof said selected liquid and generating a turbidity indiciarepresentative thereof; and, g) quality check means for repeatedlycausing said means for injecting, said surging means, and said means forflushing to operate until said turbidity indicia meets pre-selectedcriteria.
 14. The cleaning and sterilizing mechanism according to claim13, wherein said quality check means includes means for terminatingoperation of said cleaning and sterilizing mechanism after a preselectednumber of operations of said means for injecting and failure by saidturbidity indicia to meet said preselected criteria.
 15. The cleaningand sterilizing mechanism according to claim 14, wherein saidpreselected number is four.
 16. The cleaning and sterilizing mechanismaccording to claim 14, wherein said means for measuring turbidityinclude:a) a transparent tube in liquid communication with saidcontainer; b) a light transmitter directing light through saidtransparent tube; and, c) a light receiver positioned to receive lightpassing through said transparent tube from said light transmitter, saidlight receiver generating said turbidity indicia based uponinterruptions in said light over a selected period of time.
 17. Themedical cleaning apparatus according to claim 16, further includingmeans for directing a flow of liquid from said treatment mechanismthrough said transparent tube.
 18. A mechanism for cleaning medicalinstruments comprising:a) an automatic mechanism having:1) a containerhaving,A) a first chamber and a second chamber, said first chamber inliquid communication with said second chamber, and, B) holder means forsecuring a medical instrument such that a first portion of said medicalinstrument lies in said first chamber and a second portion of saidmedical instrument lies in said second chamber, and, 2) surging meansfor repetitively causing a liquid to surge between said first chamberand said second chamber past said holder means; b) a reservoirselectively communicating a selected liquid having sterilizingproperties to said first chamber, said reservoir being flexible andresponsive to ambient air pressure; c) valving means, interposed betweensaid reservoir and said first chamber, for selectively allowing flow ofsaid selected liquid from said reservoir to said first chamber whenpressure within said first chamber is less than ambient conditions; and,d) means for selectively exhausting said selected liquid from saidcontainer; e) a turbidity monitor measuring turbidity of said selectedliquid in said first chamber and generating a turbidity indiciarepresentative thereof; and, f) means for repeatedly causing saidvalving means, said surging means, and said means for selectivelyexhausting to operate until said turbidity indicia meets pre-selectedcriteria.
 19. The mechanism according to claim 18,a) wherein saidselected liquid includes a sterilizing liquid; and, b) wherein saidreservoir further includes a sterilizing reservoir containing asterilizing liquid; and, c) wherein said valving means includes meansfor selectively injecting said sterilizing liquid from said sterilizingreservoir into said container.
 20. The mechanism according to claim 19,wherein said means for measuring turbidity include:a) a transparent tubein liquid communication with said first chamber; b) a light transmitterdirecting light through said transparent tube; and, c) a light receiverpositioned to receive light passing through said transparent tube fromsaid light transmitter, said light receiver generating said turbidityindicia based upon interruptions in said light over a selected period oftime.